COVID-19, the disease caused by the novel coronavirus SARS-CoV-2, has impacted almost every aspect of our daily lives, so it’s no surprise that it’s also already affecting clinical trials around the world.
According to a report published Mar. 12 by Science 37, a company that provides services allowing for remote clinical research, there are currently 40,000 clinical trials underway worldwide that will potentially be affected by the COVID-19 pandemic.
“An infectious epidemic event like the one the world is currently facing has the potential to threaten the continuity and success of these trials, with massive detrimental economic and human impact,” the report states.
There are a few key areas where COVID-19 is likely to impact clinical trials.
COVID-19 may dissuade people from participating in clinical trials
People will be wary about going to a hospital or clinic and potentially exposing themselves to COVID-19 to participate in a clinical trial. Some sites may also be closed or access restricted due to measures put in place to limit the spread of the illness. Also, with such widespread social distancing measures in place, many people are unable to work and have had to make alternate arrangements for daycare with schools and daycare centers closed. Taking additional time off to participate in a clinical trial will therefore be even more difficult, the Science 37 paper points out.
A recent survey cited by STAT says that almost one third of clinical trials expect COVID-19 to have a large or very large effect on their ability to keep their patients enrolled in current trials or to recruit patients for new studies. Two US companies—Provention Bio and Arrowhead Pharmaceuticals—have already paused clinical trials due to COVID-19, STAT said.
With participants more likely to skip their visits due to fears of contracting COVID-19, it will be more difficult to meet the standard operating procedures clinical trials need to follow, as pointed out by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA says it will be understanding given the COVID-19 situation and has several tips for dealing with this challenge faced by pharmaceutical companies.
Possible solutions to the challenge COVID-19 presents to clinical trials
Naturally, as a provider of services enabling remote clinical trials, Science 37 says that telemedicine and virtual visits are some ways to solve the challenges COVID-19 will pose to clinical trials. Instead of having patients report to a clinical site for their scheduled visits, investigators could:
- Use software solutions to manage “virtual visits” and record data
- Use telemedicine for physician visits
- Replace in-clinic visits with in-home visits by nurses to safely collect samples, assess patients, etc.
- Ship study materials, including the drug being tested, to the patient
However, the report stresses that those performing clinical trials need to consider several factors before using a virtual model in their studies, including:
- The health condition(s) of the participants. If they are at higher risk of contracting COVID-19, this is all the more reason to implement a virtual model
- Collection of data in the patient’s home to ensure reliability
- The ability to ship the drug being tested to the patient and ensure safe and proper storage
- Any tests/procedures that still need to be done in a clinic
- The ability of the investigator to properly monitor all aspects of the trial remotely
With the COVID-19 situation evolving rapidly, more challenges to clinical trials are likely to emerge over the coming months. It will be interesting to see the solutions the pharmaceutical industry comes up with as we move forward.